Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

Comparison of Computer-Controlled and Conventional Local Anesthesia Techniques on Dental Anxiety and Pain During Mandibular Primary Molar Pulpectomy: A Split-Mouth Randomized Clinical Trial

This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care.

Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements.

The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Dental Anxiety; Pulpal Diseases
• Intervention / Treatment: Procedure: Conventional Inferior Alveolar Nerve Block; Drug: Articaine hydrochloride with epinephrine 1:100,000; Device: Standard Dental Aspirating Syringe; Procedure: Computer-Controlled Local Anesthesia; Device: Computer-Controlled Local Anesthetic Delivery System

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: dilara nil günaçar; Phone Number: +905412940104; Email: dilaranil.tomrukcu@erdogan.edu.tr

Study Locations

• Turkey (Türkiye)
  • Rize Province
    • Merkez, Rize Province, Turkey (Türkiye), 53020
      • Recep Tayyip Erdogan University
      • Contact: dilara nil günaçar; Phone Number: 05412940104; Email: dilaranil.tomrukcu@erdogan.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children aged 6 to 8 years.
• Requiring bilateral pulpectomy treatment of mandibular primary molars.
• Frankl Behavior Rating Scale score of 3 or 4.
• American Society of Anesthesiologists (ASA) Physical Status I.
• No known allergy to local anesthetic agents.
• No previous experience with dental local anesthesia.
• No signs of acute abscess or swelling in the treatment area.
• Parent or legal guardian able to provide written informed consent and child willing to participate.

Exclusion Criteria:

• ASA Physical Status II or higher.
• Known allergy or contraindication to local anesthetic agents.
• Frankl Behavior Rating Scale score of 1 or 2.
• Children receiving psychological or psychiatric treatment.
• Physical or intellectual disabilities that could interfere with study procedures.
• Previous experience with dental local anesthesia.
• Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Inferior Alveolar Nerve Block	Procedure: Conventional Inferior Alveolar Nerve Block; Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.; Drug: Articaine hydrochloride with epinephrine 1:100,000; A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.; Device: Standard Dental Aspirating Syringe; A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.
Active Comparator: Computer-Controlled Local Anesthesia	Drug: Articaine hydrochloride with epinephrine 1:100,000; A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.; Procedure: Computer-Controlled Local Anesthesia; Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.; Device: Computer-Controlled Local Anesthetic Delivery System; A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Anxiety	Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.	Baseline and immediately after treatment
Behavioral Pain During Local Anesthesia	Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain.	Immediately after local anesthetic injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Pain	Pain assessed using the Wong-Baker FACES Pain Rating Scale immediately after treatment. Self-reported pain assessed using the Wong-Baker FACES Pain Rating Scale (0-10) immediately after completion of pulpectomy. Scores range from 0 to 10, with higher scores indicating greater pain intensity.	Immediately after local anesthetic injection
Facial Image Scale (FIS) Score	Emotional status assessed using the Facial Image Scale (FIS). Higher scores indicate greater anxiety. Emotional status assessed using the Facial Image Scale (FIS). The scale ranges from 1 to 5, with 1 indicating no anxiety (very happy face) and 5 indicating severe anxiety (very unhappy face). Higher scores indicate greater anxiety.	Baseline and immediately after treatment.
Heart Rate	Heart rate measured using a pulse oximeter.	Baseline and during local anesthetic administration
Blood Pressure	Systolic and diastolic blood pressure measured with an automated monitor.	Baseline, during local anesthetic administration, and immediately after treatment
Peripheral Oxygen Saturation (SpO₂)	Peripheral oxygen saturation measured using pulse oximetry.	Baseline, during local anesthetic administration, and immediately after treatment
Body Temperature	Body temperature measured using a digital thermometer.	Baseline, during local anesthetic administration, and immediately after treatment

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 9, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Thiophenes; Biogenic Monoamines; Biogenic Amines; Catecholamines; Epinephrine; Carticaine
• Other Study ID Numbers: 2026/268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No